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Hydromide Side Effects

Generic name: homatropine / hydrocodone

Medically reviewed by Drugs.com. Last updated on Oct 14, 2023.

Note: This document provides detailed information about Hydromide Side Effects associated with homatropine / hydrocodone. Some dosage forms listed on this page may not apply specifically to the brand name Hydromide.

Applies to homatropine / hydrocodone: oral solution, oral syrup, oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet; solution)

Warning: Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; medication errors; cytochrome P450 3A4 interaction; concomitant use with benzodiazepines or other CNS depressants; interaction with alcohol; neonatal opioid withdrawal syndromeAddiction, Abuse, and Misuse. Hydrocodone bitartrate/homatropine methylbromide exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

Reserve hydrocodone bitartrate/homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

Assess each patient’s risk prior to prescribing hydrocodone bitartrate/homatropine methylbromide, prescribe hydrocodone bitartrate/homatropine methylbromide for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment.Life-Threatening Respiratory Depression. Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate/homatropine methylbromide.

Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate/homatropine methylbromide or when used in patients at higher risk.Accidental Ingestion. Accidental ingestion of even one dose of hydrocodone bitartrate/homatropine methylbromide, especially by children, can result in a fatal overdose of hydrocodone.Risk of Medication Errors. Ensure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate/homatropine methylbromide.

Dosing errors can result in accidental overdose and death.

Always use an accurate milliliter measuring device when measuring and administering hydrocodone bitartrate/homatropine methylbromide.Cytochrome P450 3A4 Interaction. The concomitant use of hydrocodone bitartrate/homatropine methylbromide with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.

In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration.

Avoid the use of hydrocodone bitartrate/homatropine methylbromide in patients taking a CYP3A4 inhibitor or inducer.Risk from Concomitant Use with Benzodiazepines or Other CNS Depressants. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Avoid the use of hydrocodone bitartrate/homatropine methylbromide in patients taking benzodiazepines, other CNS depressants, or alcohol.Interaction with Alcohol. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone bitartrate/homatropine methylbromide.

The co-ingestion of alcohol with hydrocodone bitartrate/homatropine methylbromide may result in increased plasma levels and a potentially fatal overdose of hydrocodone.Neonatal Opioid Withdrawal Syndrome. Hydrocodone bitartrate/homatropine methylbromide is not recommended for use in pregnant women.

Prolonged use of hydrocodone bitartrate/homatropine methylbromide during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

If hydrocodone bitartrate/homatropine methylbromide is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Oral route (tablet)

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

Serious side effects of Hydromide

Along with its needed effects, homatropine / hydrocodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking homatropine / hydrocodone:

More common

  • lightheadedness, dizziness, or fainting
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known

  • agitation
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • change in the ability to see colors, especially blue or yellow
  • chills
  • confusion
  • constipation
  • constricted, pinpoint, or small pupils (black part of the eye)
  • cough
  • cough producing mucus
  • dark urine
  • decrease in the frequency of urination
  • decrease in urine volume
  • diarrhea
  • difficult, painful, or troubled breathing
  • difficulty in passing urine (dribbling)
  • difficulty swallowing
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • double vision
  • feeling sad or empty
  • fever
  • general feeling of tiredness or weakness
  • headache
  • hives, itching, skin rash
  • hoarseness
  • indigestion
  • irregular, fast or slow, or shallow breathing
  • irritability
  • lack of appetite
  • loss of consciousness
  • loss of interest or pleasure
  • lower back or side pain
  • muscle aches
  • nausea
  • nervousness
  • overactive reflexes
  • pain or cramping in the stomach
  • painful urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale or blue lips, fingernails, or skin
  • poor coordination
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • restlessness
  • seeing double
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness and unsteady walk
  • shivering
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stuffy or runny nose
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • tingling of the hands or feet
  • trembling or shaking
  • trouble concentrating
  • trouble sleeping
  • twitching
  • uncontrolled movements of the face
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • vomiting
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking homatropine / hydrocodone:

Symptoms of overdose

Other side effects of Hydromide

Some side effects of homatropine / hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • dry mouth

Incidence not known

  • back pain
  • decreased appetite
  • difficulty in moving
  • drowsiness
  • false or unusual sense of well-being
  • fear or nervousness
  • feeling of warmth
  • increased sweating
  • joint pain
  • mood changes
  • muscle pain or stiffness
  • redness of the face, neck, arms and occasionally, upper chest
  • relaxed and calm
  • sleepiness
  • trouble getting pregnant

Managing side effects (general information)

For healthcare professionals

Applies to homatropine / hydrocodone: oral syrup, oral tablet.

General

The most commonly reported adverse effects have included sedation (somnolence, mental clouding, lethargy) impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation.[Ref]

Nervous system

Serotonin syndrome has been reported with concomitant opioids and serotonergic drugs[Ref]

Respiratory

Cardiovascular

Other

Gastrointestinal

Genitourinary

Hypersensitivity

Dermatologic

Psychiatric

Endocrine

Adrenal insufficiency has been reported with opioid use, most often following greater than one month of use. Androgen deficiency has been reported with chronic opioid use.

Musculoskeletal

Ocular

Metabolic

References

1. (2017) "Product Information. Homatropine Methylbromide-Hydrocodone (homatropine-hydrocodone)." KVK-Tech Inc

2. Fricke J, Halladay SC, Bynum L, Francisco CA (1993) "Pain relief after dental impaction surgery using ketorolac, hydrocodone plus acetaminophen, or placebo." Clin Ther, 15, p. 500-9

3. Sackner MA (1984) "Effects of hydrocodone bitartrate on breathing pattern of patients with chronic obstructive pulmonary disease and restrictive lung disease." Mt Sinai J Med, 51, p. 222-6

4. (2001) "Product Information. Hycodan (homatropine-hydrocodone)." Endo Laboratories LLC

5. Morrison AB (1979) "Toxicity and abuse of hydrocodone bitartrate." Can Med Assoc J, 120, p. 1338

More about Hydromide (homatropine / hydrocodone)

Patient resources

Other brands

Hydromet, Hycodan, Tussigon

Professional resources

Other brands

Hydromet, Hycodan, Tussigon

Related treatment guides

Further information

Hydromide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer